嬰兒奶嘴中亞硝胺含量之檢驗方法精進研究   全文下載

Optimization of Analytical Method for N-nitrosamines in Baby Nipple Products

亞硝胺為一類具亞硝基官能基之有機化合物，部分亞硝胺經動物實驗證實具有致癌性，生活環境中如水、食物及橡膠製用品均可發現亞硝胺之存在。由於部分嬰幼兒奶嘴由橡膠製造而成，必須對這些產品中亞硝胺含量進行控管以保障嬰兒健康。考量衛生福利部公告之嬰兒奶嘴中亞硝胺含量檢驗方法之樣品前處理流程複雜耗時，故本研究參考歐盟標準方法EN 12868中奶嘴溶出試驗，將奶嘴以人工唾液進行溶出，所得之溶出液直接以液相層析串聯質譜儀進行7項亞硝胺之定量分析。以奶嘴空白檢體之溶出液進行添加回收試驗，7項亞硝胺之平均回收率介於91.6-108.6%，變異係數介於2.3-14.7%。本方法7項亞硝胺之定量極限均為1.2 ppb，標準曲線之線性範圍為0.1-50 ng/mL，相關係數r值為0.99以上，線性關係良好。本方法簡單、快速且具良好準確性及精密度，可供各界參考使用。

N-nitrosamines are a class of organic compounds containing the nitroso group, some of which have been confirmed to be carcinogenic via animal experiments. Nitrosamines are present in the environment, including water, food, and rubber products. Since some of infant pacifiers are made of rubber, it is mandatory to control the nitrosamine content in these products to safeguard infant health. The Ministry of Health and Welfare in Taiwan has announced the“Method of Test for Nitrosamines on Baby Nipples”; however, this method involves a complex and time-consuming sample preparation process. Therefore, this study referred to the European standard method, EN 12868, where the migration test and a liquid chromatograph-tandem mass spectrometry coupled with APCI were employed to determine 7 nitrosamines in infant pacifiers. The recovery was tested by spiking 7 nitrosamines into the migration solution obtained from the blank sample treated with artificial saliva. The average recoveries for 7 nitrosamines ranged from 91.6% to 108.6% with coefficients of variation between 2.3% and 14.7%. The limits of quantification for 7 nitrosamines were all 1.2 ppb, and the linear range of the standard curve of each nitrosamine was in the range of 0.1 to 50 ng/mL, with correlation coefficients (r) higher than 0.99, indicating good linearity. This method was simple, rapid and exhibiting high accuracy and precision, and could serve as a reference for various laboratories.